Data updated: May 26, 2026
Asceniv (immune globulin intravenous, human-slra)
Approved 2019-03-31
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-03-31
- Routes
- Intravenous
- Dosage Forms
- Injection
Asceniv Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
Mar 2019 ORIGINAL
Update · CBER biologic (Purple Book)
What Asceniv Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2019)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Asceniv FDA Label Details
Track Asceniv with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.